ClarIDHy
The Study Design
What was a phase 3, randomized, placebo-controlled, multi-center study
The primary end point and hazard ratio
What is the hazard ratio was 0.37 decreasing the risk of disease progression and death by 63%
The most common adverse reactions (15%)
What is fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, vomiting, anemia, and rash?
The dose, route, and how Tibsovo is taken
What is 500 mg orally once daily with or without food?
The median OS for Tibsovo was _____ while the median OS for placebo was _____.
What is 10.3 vs. 7.5 months?
The therapies patients had to have to be eligible for the ClarIDHy study
What was 1-2 prior therapies (gem/cis and or 5-FU containing regimen)?
The percentage of patients that were progression free at 6 months and 12 months.
What is 32% and 22% (respectively)?
The most common lab abnormalities (>10%)
What are AST, Bilirubin, and Hemoglobin decrease?
If a dose is missed or not taken at the usual time
What is take the missed dose ASAP and at least 12 hours prior to the next scheduled dose and should return to the normal schedule; they should not take within 12 hours?
This confounds the OS data
What is patients were permitted to crossover for radiographic disease progression?
2 endpoints in the ClarIDHy Study
What are PFS, secondary endpoint OS, Overall response rate, safety and QOL
The disease control rate for Tibsovo vs. placebo
What is 53 % (51% stable disease + 2% partial response) vs 28% placebo?
The percentage of interruptions, dose reductions, and permanent discontinuations
What are 29%, 4.1% and 7% respectively
Tibsovo should not be _____, _____, and ____.
What is split, crushed or chewed?
The statistical methodology to address the crossover from placebo to the treatment arm
What is RPSFT or Rank Preserving Structural Failure Time?
The number of patients randomized to placebo and the percentage of patients that crossed over to receive Tibsovo
What is among 61 patients that were randomized to the placebo arm 70% of patients were allowed to cross over?
What is the median PFS for Tibsovo is 2.7 months vs. 1.4 months for placebo
The most common reaction that led to dose reduction
What is ECG QT prolongation?
The dose of Tibsovo after it has gone from greater than 500 msec to within 30 msec of baseline or less than or equal to 480 msec
What is 250 mg once daily?
When adjusted for crossover the median OS for the placebo group was ___ and the hazard ratio was ___.
What is 5.1 months with a hazard ratio of 0.49?
What is R132C?
The percentage of patients that remained on Tibsovo for over a year
What is 15%?
The most common reaction leading to permanent discontinuation
What is acute kidney injury?
It is recommended to do this with Guillain-Barre syndrome
What is permanently discontinue?
The assumption for that the RPSFT model is based on
What is that the treatment effect is of Tibsovo is the same for all individuals?